Cleared Abbreviated

SonoSite SII Ultrasound System

K183235 · FUJIFILM Sonosite, Inc. · Radiology
Feb 2019
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K183235 is an FDA 510(k) clearance for the SonoSite SII Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by FUJIFILM Sonosite, Inc. (Bothell, US). The FDA issued a Cleared decision on February 7, 2019, 79 days after receiving the submission on November 20, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K183235 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2018
Decision Date February 07, 2019
Days to Decision 79 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

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